Ovarian CancerPhase 1NCT02661815
A Phase 1b Study of Paclitaxel And Ricolinostat For The Treatment Of Gynecological Cancer
A Phase 1 study testing Paclitaxel, Ricolinostat and Bevacizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12 months of prior treatment that includes Platinum Chemotherapy are invited to take part in this study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Paclitaxel, Ricolinostat and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jun 2016to 28 Jul 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, recurrent endometrial cancer, or recurrent cervical cancer. Histologic documentation of the original primary tumor is required via the pathology report.
- Participants must have measurable disease by RECIST 1.1 criteria. See Section 11 for the evaluation of measurable disease.
- Participants must have had at least one prior platinum-based chemotherapeutic regimen for management of primary disease (e.g., a regimen containing carboplatin, cisplatin, or another organoplatinum compound). This initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab) or extended therapy administered after surgical or non-surgical assessment.
- Participants are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen.
- Participants must have recurrence within 12 months of their last platinum-containing regimen.
- Age 18 years or older
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- ECOG performance status 0 or 1
- Life expectancy of greater than 16 weeks
- Participants must have normal organ and marrow function as defined below:
- Leukocytes ≥3,000/mcL
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥100,000/mcL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- Creatinine within normal institutional limits OR
- Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- Previous toxicities from previous treatment must have resolved to grade 1 or less
- For patients in expansion cohort B, stable Grade 2 neuropathy will be allowed.
- The effects of both paclitaxel and oral ricolinostat on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Participants must be able and willing to swallow pills and to absorb oral medications.
- Ability to understand and the willingness to sign a written informed consent document
- Participants must be able and willing to follow protocol instructions and schedules.
Who cannot join
- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. In addition, no small molecule kinase inhibitors or any other type of investigational agent may have been administered within 4 weeks before first dose of study treatment.
- Participants may not be receiving any other investigational agents for treatment of their cancer.
- No hormonal therapy is allowed within 1 week of initiating study treatment.
- Participants may not have had radiation to >25% of the bone marrow.
- Prior treatment with a histone deacetylase inhibitor.
- Prior treatment with weekly paclitaxel for recurrent or persistent disease is not allowed. Participants may have received weekly paclitaxel as part of treatment for newly diagnosed cancer, but may not have received it as maintenance therapy following their initial therapy with platinum and taxane therapy.
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- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to either paclitaxel or Ricolinostat. Patients who require administration of paclitaxel through a desensitization procedure are not eligible for this study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with chronic viral illnesses such as HIV-positivity and active hepatitis B or C are ineligible because they are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- Any signs, symptoms, and/or radiographic evidence of a complete or partial bowel obstruction
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted below, are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- Carcinoma in situ of the breast or cervix
- Primary endometrial cancer meeting the following conditions: Stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions.
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
- Patients with clinically significant cardiovascular disease. This includes:
- Uncontrolled hypertension, defined as systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg despite antihypertensive medications.
- Myocardial infarction or unstable angina within 6 months prior to registration.
- New York Heart Association (NYHA) Class II or greater congestive heart failure. (see Appendix III )
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication. This does not include asymptomatic atrial fibrillation with controlled ventricular rate.
- Any history of congenital long QT syndrome
- The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) >500 ms within 28 days before randomization. Note: if initial QTcF is found to be > 500 ms, two additional EKGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤500 ms, the subject meets eligibility in this regard.
- Patients with serious non-healing wound, ulcer, or bone fracture within 28 days before registration
- Patients with history of organ transplant.
- Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving (in contact with, invading or encasing) major vessels.
- Gastrointestinal disorders, particularly those with potential risk of perforation or fistula formation including:
- Any of the following within 28 days of registration
- Intra-abdominal tumor/metastases invading GI mucosa
- Active peptic ulcer disease
- Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis
- Malabsorption syndrome.
- Any of the following within 6 months of registration
- Abdominal fistula
- Gastrointestinal perforation
- Bowel obstruction or gastric outlet obstruction
- Note: Patients requiring drainage gastrostomy (e.g., PEG tube) and/or parenteral hydration and/or nutrition are not eligible.
- Intraabdominal abscess.
- Note: Complete resolution of an intraabdominal abscess must be confirmed prior to registration even if the abscess occurred more than 6 months prior to registration.
- Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, any brain metastases and/or epidural disease, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment.
- Major surgery within 3 months of the first dose of study drugs if there were no wound healing complications or within 6 months of the first dose of study drugs if there were wound complications.
- The following are additional exclusion criteria for patients enrolling in Expansion Cohort C:
- Uncontrolled blood pressure (>140/90). Patients should have a blood pressure of ≤140/90 taken by a medical professional within one week of starting on study
- Proteinuria >2+ on urinalysis
- Serosal involvement of the bowel that would render the patient at increased risk of gastrointestinal perforation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massacusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase 1b Study of Weekly Paclitaxel And Oral Ricolinostat For The Treatment Of Recurrent Platinum Resistant Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer
Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12 months of prior treatment that includes Platinum Chemotherapy are invited to take part in this study. This research study is studying a combination of a new chemotherapy drug called Ricolinostat together with the chemotherapy Paclitaxel and a drug called Bevacizumab as a possible treatment for this diagnosis.
Read the detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.
The FDA (the U.S. Food and Drug Administration) has not approved Ricolinostat as a treatment for any disease. The FDA has approved Paclitaxel as a treatment option for Ovarian, Fallopian Tube, or Peritoneal Cancer . The FDA has approved Bevacizumab in combination with chemotherapy as a treatment option for Ovarian, Fallopian Tube, or Peritoneal Cancer .
In this study, we are hoping to learn what is the highest dose of Ricolinostat that can be given safely together with Paclitaxel on a weekly basis or with Paclitaxel on a weekly basis and Bevacizumab every other week. Ricolinostat is a drug that stops cancer from growing by blocking the action of a protein called HDAC.
- Being tested
- Paclitaxel, Ricolinostat, Bevacizumab
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
Please see arm/group description.
RicolinostatDrug
Also called ACY-1215
Please see arm/group description.
BevacizumabDrug
Also called Avastin
Please see arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Expansion Cohort A | Experimental | Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose Receives: Drug: Paclitaxel; Drug: Ricolinostat |
| Phase 1 Expansion Cohort B | Experimental | Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose Receives: Drug: Paclitaxel; Drug: Ricolinostat |
| Phase 1 Expansion Cohort C | Experimental | Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose Receives: Drug: Paclitaxel; Drug: Ricolinostat; Drug: Bevacizumab |
| Phase 1 Escalation Cohort | Experimental | Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks). Receives: Drug: Paclitaxel; Drug: Ricolinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis Report on the MTD In The Dose Escalation Portion Of The Study
Not assessed, the MTD was not reached as the study was terminated.
Measured: 2 years
Best Overall Response Measured From, Start Of Treatment To The End
This is now the primary outcome measure as the study was terminated prematurely.
Measured: 13 months
Secondary outcomes (3)
Peripheral Neurotoxicity Assessed Using TNS by Measuring 5 Categories
No assessed TNS would only be assessed during escalation which we did not reach as the study was terminated.
Measured: 0 years
Duration Of Overall Response, Measured From The Time Measurement Criteria Are Met For PR or CR Until The First Date Recurrent Or Progressive Disease Is Objectively Documented.
Not assessed, study was terminated.
Measured: 2 years
Progression-free Survival (PFS)
No assessed, study was terminated.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start15 Jun 2016
- Primary completion28 Jun 2017
- Study completion28 Jul 2017
Why it stopped: Company decided not to move forward with further accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Principal investigator, Joyce Liu, MD, Dana-Farber Cancer Institute
- Investigators
- Joyce Liu, MD MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661815
- Sponsor's protocol ID
- 15-483
- Status last verified
- Nov 2019
- First submitted
- 20 Jan 2016
- Last updated
- 8 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Weekly Paclitaxel And Oral Ricolinostat For The Treatment Of Recurrent Platinum Resistant Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT02661815
- Acronym / sponsor ID
- 15-483
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decided not to move forward with further accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Posted 8 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12 months of prior treatment that includes Platinum Chemotherapy are invited to take part in this study. This research study is studying a combination of a new chemotherapy drug called Ricolinostat together with the chemotherapy Paclitaxel and a drug called Bevacizumab as a possible treatment for this diagnosis.
Detailed description
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.
The FDA (the U.S. Food and Drug Administration) has not approved Ricolinostat as a treatment for any disease. The FDA has approved Paclitaxel as a treatment option for Ovarian, Fallopian Tube, or Peritoneal Cancer . The FDA has approved Bevacizumab in combination with chemotherapy as a treatment option for Ovarian, Fallopian Tube, or Peritoneal Cancer .
In this study, we are hoping to learn what is the highest dose of Ricolinostat that can be given safely together with Paclitaxel on a weekly basis or with Paclitaxel on a weekly basis and Bevacizumab every other week. Ricolinostat is a drug that stops cancer from growing by blocking the action of a protein called HDAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Expansion Cohort A | Experimental | Drug: Paclitaxel, Drug: RicolinostatPaclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose |
| Phase 1 Expansion Cohort B | Experimental | Drug: Paclitaxel, Drug: RicolinostatPaclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose |
| Phase 1 Expansion Cohort C | Experimental | Drug: Paclitaxel, Drug: Ricolinostat, Drug: BevacizumabPaclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose |
| Phase 1 Escalation Cohort | Experimental | Drug: Paclitaxel, Drug: RicolinostatRicolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Participants must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, recurrent endometrial cancer, or recurrent cervical cancer. Histologic documentation of the original primary tumor is required via the pathology report.
- Participants must have measurable disease by RECIST 1.1 criteria. See Section 11 for the evaluation of measurable disease.
- Participants must have had at least one prior platinum-based chemotherapeutic regimen for management of primary disease (e.g., a regimen containing carboplatin, cisplatin, or another organoplatinum compound). This initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab) or extended therapy administered after surgical or non-surgical assessment.
- Participants are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen.
- Participants must have recurrence within 12 months of their last platinum-containing regimen.
Key exclusion criteria (44 listed)
- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. In addition, no small molecule kinase inhibitors or any other type of investigational agent may have been administered within 4 weeks before first dose of study treatment.
- Participants may not be receiving any other investigational agents for treatment of their cancer.
- No hormonal therapy is allowed within 1 week of initiating study treatment.
- Participants may not have had radiation to >25% of the bone marrow.
- Prior treatment with a histone deacetylase inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelAlso: TaxolPlease see arm/group description. | Drug | Phase 1 Escalation Cohort, Phase 1 Expansion Cohort A, Phase 1 Expansion Cohort B, Phase 1 Expansion Cohort C |
| RicolinostatAlso: ACY-1215Please see arm/group description. | Drug | Phase 1 Escalation Cohort, Phase 1 Expansion Cohort A, Phase 1 Expansion Cohort B, Phase 1 Expansion Cohort C |
| BevacizumabAlso: AvastinPlease see arm/group description. | Drug | Phase 1 Expansion Cohort C |
Primary outcome
Analysis Report on the MTD In The Dose Escalation Portion Of The Study
Time frame: 2 years
Not assessed, the MTD was not reached as the study was terminated.
Best Overall Response Measured From, Start Of Treatment To The End
Time frame: 13 months
This is now the primary outcome measure as the study was terminated prematurely.
3 secondary outcomes
Peripheral Neurotoxicity Assessed Using TNS by Measuring 5 Categories
Time frame: 0 years
Duration Of Overall Response, Measured From The Time Measurement Criteria Are Met For PR or CR Until The First Date Recurrent Or Progressive Disease Is Objectively Documented.
Time frame: 2 years
Progression-free Survival (PFS)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Liu, MD MPH principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paclitaxel, Ricolinostat and Bevacizumab in people with Ovarian Cancer and Fallopian Tube Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis Report on the MTD In The Dose Escalation Portion Of The Study (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.